Drug factory · FDA FEI 3007577023
Summit Biosciences Inc.
1513 Bull Lea Road, Lexington, KY, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 21, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2015: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Naloxone | Makes it, tests it, packages it and labels it | Scienture LLC | 83245-003 |
| Sumatriptan | Makes it, tests it, packages it and labels it | Lannett Company, Inc. | 0527-1818, 0527-1859 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 21, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Feb 4, 2020 | No problems found | Drug Quality Assurance | — |
| Jun 23, 2017 | No problems found | Drug Quality Assurance | — |
| Jun 18, 2015 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 21, 2025 inspection
- Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established that describe the in-process controls and examinations to be conducted on appropriate samples of in-process materials of each batch. - Systems in place to comply with verification requirements FDCA 582(b)(4)
Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
Registered with FDA for: analysis; label; manufacture; pack.